BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE

    MDR report key: 7532326 · Received May 22, 2018

    Report

    Report Number
    3004444684-2018-00002
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    April 25, 2018
    Report Date
    April 25, 2018
    Manufacturer
    MEDIGUS LTD
    Product Code
    ODE
    UDI-DI
    07290014036062
    PMA / PMN Number
    K132151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENDOSTAPLER FUNCTIONED AS EXPECTED DURING THE ENTIRE PROCEDURE. A REVIEW OF MANUFACTURING, DEVICE HISTORY, AND QUALITY CONTROL RECORDS FOUND THAT THE DEVICE MET ALL SPECIFICATIONS AND WAS IN COMPLIANCE. THERE WERE NO FINDINGS TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED IN ANY WAY TO THE PATIENT'S INJURY.

    Description of Event or Problem · 1

    THE FUNDOPLICATION PROCEDURE WAS DONE ON (B)(6). THE NEXT DAY, THE MEDIGUS REPRESENTATIVE LEARNED THAT, SEVERAL HOURS AFTER THE PROCEDURE, THE FEMALE PATIENT HAD SEVERE CHEST PAIN. THE CT SCAN WAS ABNORMAL, INDICATING PLEURAL EFFUSION, PNEUMOMEDIASTINUM AND AN ESOPHAGEAL PERFORATION OF 1 CM. LAPAROSCOPIC SURGERY WAS DONE TO REPAIR THE PERFORATION. PATIENT WAS STABLE TWELVE HOURS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374257 MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE ENDSTAPLER ODE MEDIGUS LTD MUSE ENDOSTAPLER 07290014036062

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R